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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR IVACAFTOR; IVACAFTOR, TEZACAFTOR

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Clinical Trials for Ivacaftor; Ivacaftor, Tezacaftor

Trial ID Title Status Sponsor Phase Summary
NCT02951182 A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis Recruiting Vertex Pharmaceuticals Incorporated Phase 2 This is a Phase 2, randomized, double-blind, placebo- and active-controlled, parallel group, multicenter study to evaluate the safety, tolerability, and efficacy of VX-440 in dual and triple combination with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF).
NCT02951195 A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis Recruiting Vertex Pharmaceuticals Incorporated Phase 2 This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del).
NCT03150719 A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF) Recruiting Vertex Pharmaceuticals Incorporated Phase 3 Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the CFTR gene and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment. This study is designed to evaluate the safety and efficacy of TEZ/IVA.
NCT03224351 A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Not yet recruiting Vertex Pharmaceuticals Incorporated Phase 2 This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (TEZ/IVA)-controlled, parallel-group, 2-part, multicenter study designed to evaluate the safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).
NCT03447249 A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Active, not recruiting Vertex Pharmaceuticals Incorporated Phase 3 This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects)
NCT03447262 A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy Enrolling by invitation Vertex Pharmaceuticals Incorporated Phase 3 This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF), including but not limited to those who are heterozygous for the F508del mutation
NCT03460990 A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F) Active, not recruiting Vertex Pharmaceuticals Incorporated Phase 3 This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ivacaftor; Ivacaftor, Tezacaftor

Condition Name

Condition Name for Ivacaftor; Ivacaftor, Tezacaftor
Intervention Trials
Cystic Fibrosis 17
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Condition MeSH

Condition MeSH for Ivacaftor; Ivacaftor, Tezacaftor
Intervention Trials
Cystic Fibrosis 17
Fibrosis 15
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Clinical Trial Locations for Ivacaftor; Ivacaftor, Tezacaftor

Trials by Country

Trials by Country for Ivacaftor; Ivacaftor, Tezacaftor
Location Trials
United States 188
Canada 10
Australia 8
Germany 4
United Kingdom 4
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Trials by US State

Trials by US State for Ivacaftor; Ivacaftor, Tezacaftor
Location Trials
Pennsylvania 9
Ohio 9
New York 9
Massachusetts 9
Florida 9
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Clinical Trial Progress for Ivacaftor; Ivacaftor, Tezacaftor

Clinical Trial Phase

Clinical Trial Phase for Ivacaftor; Ivacaftor, Tezacaftor
Clinical Trial Phase Trials
Phase 3 11
Phase 2 4
Early Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Ivacaftor; Ivacaftor, Tezacaftor
Clinical Trial Phase Trials
Recruiting 9
Not yet recruiting 4
Active, not recruiting 2
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Clinical Trial Sponsors for Ivacaftor; Ivacaftor, Tezacaftor

Sponsor Name

Sponsor Name for Ivacaftor; Ivacaftor, Tezacaftor
Sponsor Trials
Vertex Pharmaceuticals Incorporated 14
University of Alabama at Birmingham 2
Proteostasis Therapeutics, Inc. 1
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Sponsor Type

Sponsor Type for Ivacaftor; Ivacaftor, Tezacaftor
Sponsor Trials
Industry 15
Other 2
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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Merck
Express Scripts
Deloitte
McKesson
QuintilesIMS
McKinsey
Queensland Health
Federal Trade Commission

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